INDICATIONS AND USAGE Hypertension Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 18, 1995 | Original application | Approved | None posted |
| Mar 17, 2025 | Supplement 51Labeling · Standard review | Approved | None posted |
| Jun 8, 2015 | Supplement 38Labeling · Standard review | Approved | None posted |
| Jun 23, 2014 | Supplement 33Manufacturing | Approved | None posted |
| Oct 25, 2011 | Supplement 34Labeling | Approved | None posted |
| Oct 21, 2008 | Supplement 27Labeling | Approved | None posted |
| Dec 12, 2005 | Supplement 25Labeling | Approved | None posted |
| Jul 19, 2004 | Supplement 22Labeling | Approved | None posted |
| May 25, 2004 | Supplement 24Labeling | Approved | None posted |
| Sep 10, 2001 | Supplement 20Manufacturing | Approved | None posted |
| Feb 20, 2001 | Supplement 19Manufacturing | Approved | None posted |
| Feb 20, 2001 | Supplement 18Manufacturing | Approved | None posted |
| Nov 2, 2000 | Supplement 16Manufacturing | Approved | None posted |
| Nov 2, 2000 | Supplement 14Manufacturing | Approved | None posted |
| Aug 10, 2000 | Supplement 17Labeling | Approved | None posted |
| Jun 9, 2000 | Supplement 15Labeling | Approved | None posted |
| Jan 24, 2000 | Supplement 13Manufacturing | Approved | None posted |
| Dec 2, 1999 | Supplement 12Manufacturing | Approved | None posted |
| Dec 2, 1999 | Supplement 11Manufacturing | Approved | None posted |
| Feb 12, 1999 | Supplement 6Manufacturing | Approved | None posted |
| Feb 12, 1999 | Supplement 5Manufacturing | Approved | None posted |
| Aug 1, 1997 | Supplement 4Manufacturing | Approved | None posted |
| Jan 28, 1997 | Supplement 3Labeling | Approved | None posted |
| Sep 13, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Aug 16, 1996 | Supplement 1Manufacturing | Approved | None posted |
| Jan 18, 1995 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
